Study Responsible Scientist Job Listing at Kelly Services in Raritan, NJ (Job ID 9437884)

Description

Kelly Services is currently seeking a Senior Clinical Project Scientist (Associate Director) for a long-term engagement with one of our Global Pharmaceutical clients.

This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you will be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You will also be eligible for paid time off, including holiday, vacation, and sick/personal time.

PRINCIPAL RESPONSIBILITIES:

• Partners with Study Responsible Physician SRP to provide clinical oversight to the study.
• Develops clinical research protocols, study case report forms, informed consent.
• Develops the medical review plan to support the statistical analysis plan.
• Plays a key role in the medical review of the study data and assists in coding, analysis and documentation
• Validates and interprets results of phase I - IV investigations in preparing new drug applications to the appropriate health authorities, scientific congresses, and peer-reviewed journals
• Ensures team member adherence to clinical research guidelines and safety procedures.
• Communicates detailed outcomes and results of research findings to relevant partners.
• Provides input in managing project budgets and projections.
• Serves as liaison to global clinical sites for medical questions related to the clinical research trial
• Presents study status at internal/external meetings, including investigator meetings and governance committees
• Trains and mentors local/central study teams and investigative sites on the study protocol, ensuring they have the necessary guidance and tools for performance of various project activities
• Participates in/leads interactions with health authorities.
• Maintains expertise on clinical trial documentation, requirements, regulations, operational procedures, study file requirements, regulatory requirements, policies.
• Reviews and maintains correct standard operations, procedures and protocol

EDUCATION AND EXPERIENCE REQUIREMENTS:

• A minimum of a bachelors degree is required; and advanced degree (M.D., Ph.D. Pharm.D.) is preferred.
• A minimum of 3 years of clinical research and development, or related experience within the industry pharmaceutical, biotech, CRO, etc. is required.
• Experience in oncology therapeutic area is required, preferably CAR T and or Multiple Myeloma
• Significant experience with clinical trials including development of protocols, case report forms, informed consent and study initiation and monitoring preferred.
• Excellent written communication, oral communication, and presentation skills are required.
• The individual must have demonstrated ability to work in a team environment.
• Ability to travel up to 10% required.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

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